The present invention relates to sterile medical injection ports, and more particularly to a new, easy-to-use sterile medical injection port and covering apparatus for hospital and home use.
1. Field of the Invention.
There are many hospital and home care situations where prolonged and frequent access to venous circulation is often necessary for proper patient treatment. Treatments for chronic illnesses, cancer, bacterial infections, AIDS, or those in need of parenteral nutrition or blood transfusions often require repeated daily or even hourly venous punctures. In order to avoid continuous skin punctures in these and other situations, medical Venous Access Devices (VADs) and injection ports have been developed. VADs are also known by such names as atrial catheters, central lines, and central venous catheters.
Presently, there are two basic types of VADs, (a) Partially Implanted Devices (PIDs), and (b) Totally Implanted Devices (TIDs). PIDs may be for short term use where one end of the catheter is inserted into a blood vessel and the other end (where the injection port is located) protrudes from the skin. PIDs may also be for long term use where a catheter is surgically implanted under the skin (under anesthesia), usually in the upper abdomen or chest area, to a vein insertion site. Short term PIDs have been used as long as six months; whereas, long term PIDs have been maintained for more than 2 years.
Totally Implanted Devices (TIDs) such as the Mediport.RTM. generally consist of one end of the catheter inserted into a deep venous blood vessel. Placement is similar to a long term PID. However, the access end of a TID is generally in the form of an internal injection port below the surface of the skin.
External injection ports are most commonly used in PIDs. Existing external port devices (i.e. outside of the skin) include a covering membrane or septum which is made of thick silicone or latex. Special needles are required to access the injection port. Such needles have a sharply beveled tip which slices the septum when inserted. When the needle is removed, the septum then reseals. External injection ports must be periodically replaced after repeated punctures.
2. Description of the Prior Art.
The Broviac.RTM. catheter (a PID) is a long term small diameter flexible catheter. The Broviac.RTM. includes a length of small diameter tubing one end of which is threaded to a desired site inside the body, the other end of which (the access end) dangles from an external opening in the skin. It lies relatively flat against the body after the dressing is in place, and can easily be coiled and secured with tape. The Hickman.RTM. catheter (also a PID) has a larger diameter and is used when large volumes of blood, medications, and/or chemotherapy are administered. Single, double and triple access catheters of various sizes are in use in the art.
Surprisingly, no existing injection port is designed for use with a covering for protecting the access port while it is not in use. Some ports include screw threads which allow them to more easily be connected to IV tubing during lengthy accesses. However, most external injection ports normally remain uncovered and completely exposed to the outside world so that the sealed septum membrane is the only barrier to potential contaminants. These contaminants include, but are not limited to, germs, bacteria, air, dirt, clothing, skin and perspiration. Injection ports (especially those attached to the dangling Broviac.RTM. catheter) are also exposed to potential trauma and rough handling. Children and other unknowing patients may subject the port to damage from the insertion of dirty sharp objects or playthings, chewing on the port, etc. Also, exposure of the latex port septum to agents such as ozone, oxygen, and ultra violet light can cause the latex to break down over time.
Because of the exposure of the injection port to contaminants, the use of an aseptic cleansing procedure is required prior to accessing the port for administration of medication. Using currently accepted techniques, the cleansing process alone involves several steps and the use of numerous materials for each port access. In order to assure an aseptic environment, a second person is needed to assist the first with the cleansing process. This is because the iodine and alcohol swabs are sealed inside sterile pouches, the outsides of which are not sterile. Hence, touching the outside with a sterile glove contaminates the glove. The second person opens the pouches allowing the first to remove the contents. Otherwise, the first person contaminates his/her gloves by opening the pouches.
A typical example of an external injection port access and cleansing procedure includes the following time consuming steps:
______________________________________ Steps Equipment ______________________________________ 1. Wash hands 2. Put on sterile gloves 1 pair of gloves (RN only) 3. Assistant opens first alcohol swab package 4. RN wipes injection port 1 alcohol swab with alcohol 5. Assistant opens first 1 povidone iodine povidone iodine swab swab 6. RN takes swab and wipes injection port with it 7. Assistant opens second 1 povidone iodine povidone iodine swab swab 8. RN takes swab and wipes injection port with it 9. Assistant opens third 1 povidone iodine povidone iodine swab swab 10. Wait 30 seconds after third iodine wipe 11. Assistant opens first 1 alcohol swab alcohol swab 12. RN takes swab and wipes injection port with it 13. Assistant opens second 1 alcohol swab alcohol swab 14. RN takes swab and wipes injection port with it 15. Assistant opens third 1 alcohol swab alcohol swab 16. RN takes swab and wipes injection port with it 17. Access port; administer medication 18. Leave injection port dangling and exposed ______________________________________
Then, as soon as the port is released, it will come into contact with the patient's skin or clothing and immediately become dirty again, making the above procedure necessary the next time the port is accessed. These cumbersome techniques and materials are required because of the poor design of the current art. In a hospital or clinic setting, trained nurses generally perform the procedure. However, despite having the best of intentions and necessary training, the pressures of the moment, combined with occasional unavailability of the required medical supplies or personnel (e.g. only 1 alcohol swab instead of 3, no assistant available, etc.) can result in missed steps or failure to follow proper procedures.
The cleansing procedure, if properly followed, is very time consuming. Materials must be gathered prior to access, and an assistant must be available before the procedure can be started. Then, the procedure itself, as outlined above, requires careful and strict performance of a long series of time consuming aseptic steps, and results in a messy accumulation of used swabs and stains when the procedure is completed.
In a home setting, rigorous and extensive training of the involved family members is required. They must understand the principles of aseptic technique and catheter safety, as well as the specific tasks of dressing changes, changing injection ports, and emergency measures. Even with such training, these steps can seem complicated to the ordinary user resulting in missed or poorly performed steps which can compromise asepsis, thereby increasing the risk of infection. The more frequent the access, the greater the risk. Often, home care providers will erroneously conclude that if the injection port was cleaned once early in the day, it need not be cleaned again that day, or a lesser cleansing procedure is required for subsequent accesses that day. In other situations, the very condition for which the patient is being treated (e.g. AIDS, cancer, etc.) places them at greater risk of infection and death, making the need for asepsis of paramount importance.
An average cost to a hospital for a pair of sterile gloves is in the range of three dollars. An average home care cost for sterile gloves is usually higher, in the range of five dollars per pair. An average hospital cost for a box of isopropyl alcohol wipes is in the range of two dollars. An average home care cost for the same box again is higher, usually in the range of twelve dollars. An average hospital cost for a box of povidone iodine pads is in the range of three dollars. An average home care cost for the same box is higher, usually in the range of twenty dollars.
Thus, an average hospital cost (materials only, not labor) of sterile supplies for each injection port access may be in the range of seven dollars ($7.00) per access. Multiple daily accesses compound and increase these costs even more. Every external injection port must be accessed at least once a day for the application of heparin to prevent clotting. The costs of such materials for home care services are generally much higher, as set forth above, and can easily be double or triple the hospital costs. Thus, on a typical multiple access day, a home care provider may spend well over thirty dollars ($30.00) simply for materials to clean and access the dirty dangling injection port.
Recent scientific studies have concluded that the external injection port, sometimes called the catheter hub, is the place of origin of bacteria infecting catheter tips. These studies recommend that manipulation of the hub be kept at a minimum, and that a more rigorous approach to aseptic technique be undertaken. However, as described above, these are time consuming, expensive and difficult measures. One study suggests that the hub be properly covered. However, this study fails to propose any cover design, and instead simply indicates that new designs are needed to assure better protection against environmental soiling.
All external injection ports should have protective coverings in order to maintain the aseptic integrity of the port and medical tubing, and to reduce the risk of infection or other complications stemming from unwanted external environmental factors. However, despite this great need, no suitable cover has ever been developed.